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FDA Advisory Committee weighs up mitochondrial replacement

03 March 2014

By Chee Hoe Low

Appeared in BioNews 744

The USA's Food and Drug Administration (FDA) is considering whether to allow human clinical trials of mitochondrial replacement, an IVF technique that uses gametes from three people.

In a two-day-long public hearing, the advisory committee, led by Dr Evan Snyder of Sanford-Burnham Medical Research Institute in La Jolla, California, heard medical evidence from scientists on the technique's safety in humans. Issues discussed included risks posed to the mother and child, results of similar studies in animals, and further research required.

Supporters argued that the technique, if allowed, could be used to prevent mitochondrial diseases. Some critics, however, said this would lead to 'designer babies'. Regardless, scientists were asked to advise only on the scientific implications of the technique, not its legal or ethical implications.

The hearing was prompted when Dr Shoukhrat Mitalipov, researcher from the Oregon Health and Science University in Portland, USA, sought the FDA's approval to begin testing the technique on women with mitochondrial disease. Dr Mitalipov told the committee that his research team had successfully performed the technique on monkeys, and that it is now ready to be tried on humans.

Mitochondrial replacement involves replacing an egg's faulty mitochondria with healthy mitochondria from a donor's egg, either before or after fertilisation. The egg will retain DNA from the nucleus of the mother-to-be and the healthy mitochondrial DNA from the donor. The resulting child will not inherit the genetic disease, but will inherit traits like eye colour and height from the parents.

More than 4,000 children are born with inherited mitochondrial diseases every year. Mitochondrial diseases can be impossible to diagnose prenatally and are incurable. If successful, mitochondrial replacement could potentially prevent such diseases from being passed down to a child.

Dr Snyder noted that some committee members expressed concern over the safety of the trial on humans.

'There was probably not enough data in animals… to move on to human trials without answering a few additional questions [about safety]', he said at the end of the hearing.

Jennifer Rodriguez, an FDA press officer, told Reuters: 'We have heard the concerns expressed at the advisory committee meeting, and will take the information back to consider whether we need to facilitate a public discussion and, if so, how best to do this'.

Reuters | 25 February 2014
CNN | 27 February 2014
New York Times | 25 February 2014
USA Today | 24 February 2014
NBC News | 26 February 2014


08 February 2016 - by Kirsty Oswald 
Clinical investigations of mitochondrial donation are 'ethically permissable', says a panel of experts reporting to the US Food and Drug Administration...
21 July 2014 - by Professor Vardit Ravitsky, Dr John Appleby, Professor Stephen Wilkinson, Dr Anthony Wrigley and Dr Annelien Bredenoord 
Ethical dimensions of the emerging technology of mitochondrial replacement were the focus of a symposium that took place on 25 June at the 12th World Congress of Bioethics in Mexico City....
24 March 2014 - by Professor Janna Thompson 
MP Jacob Rees-Mogg recently implied that mitochondrial transfer is akin to eugenics, but it is a way of combating debilitating ailments rather than producing 'perfect' human beings...
17 March 2014 - by Dr Louisa Petchey 
The Conservative MP for North East Somerset, Jacob Rees-Mogg, has said that mitochondrial donation will produce 'genetically modified children' with 'three parents', and was 'effectively cloning'...

21 October 2013 - by Ruth Saunders 
The health regulator in the USA is considering whether clinical trials of mitochondrial replacement techniques should go ahead....
14 October 2013 - by Dr Rosie Gilchrist 
A group of European parliamentarians has criticised UK proposals to legislate for mitochondrial replacement therapy, calling it 'a eugenic practice'...
23 September 2013 - by Dr Rosie Gilchrist 
A group of scientists has expressed concerns that it may be too soon to bring mitochondrial replacement techniques, which are still under development, to the clinic....
01 July 2013 - by Dr Rosie Gilchrist 
The UK Government is to support the introduction of mitochondrial replacement therapy. The IVF-based procedure could allow women with mitochondrial disease the opportunity to have healthy children, by replacing their own, faulty, mitochondria with healthy mitochondria from a donor....

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